Inavolisib and Phesgo Trial for Metastatic Breast Cancer
Trial details
Overview: This study is officially called A Study to Evaluate the Efficacy and Safety of Inavolisib in Combination With Phesgo Versus Placebo in Combination With Phesgo in Participants With PIK3CA-Mutated HER2-Positive Locally Advanced or Metastatic Breast Cancer.
The study is designed to see if combining the experimental medicine inavolisib, a type of targeted therapy called a PI3K inhibitor, with the anti-HER2 medicine Phesgo (chemical name: pertuzumab, trastuzumab, and hyaluronidase-zzxf) as maintenance therapy offers better results than Phesgo alone for locally advanced or metastatic HER2-positive breast cancer with a PIK3CA mutation after initial treatment with Phesgo and taxane chemotherapy.
Phase: Phase III; Phase III trials compare the safety and effectiveness of a new treatment to the current standard of care. Phase III trials are usually large – some involve thousands of people – and are done at many places in the United States and around the world.
Number of people to enroll: 230
ClinicalTrials.gov ID number: NCT05894239
Sponsor of the trial: Hoffman-LaRoche
Who is the trial for?
The trial is for adults diagnosed with locally advanced or metastatic HER2-positive breast cancer with a PIK3CA mutation who have not yet received treatment for advanced-stage disease.
Why is the trial being done?
The INAVO120 study found that inavolisib combined with Ibrance (chemical name: palbociclib) and Faslodex (chemical name: fulvestrant) more than doubled how long people lived without the cancer growing compared to Ibrance and Faslodex alone in people diagnosed with advanced-stage, hormone receptor-positive, HER2-negative breast cancer with a PIK3CA mutation.
Because of the way inavolisib works, researchers think it also may be effective against other types of breast cancer with a PIK3CA mutation, including HER2-positive breast cancer.
Inavolisib is a pill taken by mouth.
Phesgo is an injection given under the skin in the thigh.
All the people in the study will receive what the researchers are calling induction therapy. This consists of Phesgo and taxane chemotherapy. Taxane chemotherapy medicines include Taxol (chemical name: paclitaxel) and Taxotere (chemical name: docetaxel).
After the induction therapy is completed, the people will be divided into two maintenance therapy treatment groups.
The first group will take inavolisib once a day and will also receive a Phesgo injection on the first day of each 21-day treatment cycle.
The second group will take a placebo, a pill that looks just like inavolisib but contains no medicine, once a day and will also receive a Phesgo injection on the first day of each 21-day treatment cycle.
If the breast cancer is hormone receptor-positive, the people in the study also will receive their doctors’ choice of hormonal therapy.
Follow-up will be about nine years to see if adding inavolisib to Phesgo improves progression-free survival and overall survival. Progression-free survival is how long someone lives without the cancer growing. Overall survival is how long a person lives whether or not the cancer grows.
Specific eligibility requirements
People are eligible for the study if they:
have been diagnosed with locally advanced or metastatic HER2-positive breast cancer with a PIK3CA mutation
haven’t yet received treatment for the locally advanced or metastatic breast cancer
People are not eligible for the study if they:
have a history of inflammatory bowel disease
had early-stage cancer come back (recur) within six months of receiving an anti-HER2 medicine
have type 2 diabetes requiring ongoing treatment or any history of type 1 diabetes
have liver disease
Read the detailed eligibility requirements.
Side effects
In the INAVO120 study, the most common side effects of inavolisib included:
anemia (low red blood cell count)
high blood sugar levels
The most common side effects of Phesgo when given with Taxotere to treat metastatic breast cancer include:
peripheral neuropathy (numbness, tingling, or pain in the hands and feet)
Study locations
The study is being conducted at multiple locations across the United States and around the world, including sites in South America, Australia, Canada, Asia, and Africa.
For more information or to enroll
In the United States, call 888-662-6728. People in any country can email global-roche-genentech-trials@gene.com. When calling or emailing, refer to study ID number WO44263.
— Last updated on September 15, 2024 at 2:53 PM